FDA.reportPublic FDA data

OSOM iFOB Control Kit

Primary DI
00742860100185
Brand
OSOM iFOB Control Kit
Company
SEKISUI DIAGNOSTICS, LLC
Model
1000
Catalog number
1000
Device description
OSOM iFOB Control Kit
Published
2017-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OSLControl, fecal occult blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSLControl, Fecal Occult BloodHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00742860100185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742860100185007428601001857428601001850742860100185

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850093003033InSure FITENTERIX INC.OSL2016-09-20